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Zocor Exclusivity: Ranbaxy Needs Quick Win In Suit Seeking Patent Re-Listing

Executive Summary

Ranbaxy needs a relatively quick win in its lawsuit against FDA if it hopes to benefit from the 180-day exclusivity it is claiming for Zocor 80 mg

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Ivax to join Zocor court battle

Ivax files suit against FDA on Nov. 7 claiming exclusivity rights for Merck's cholesterol-lowering agent Zocor (simvastatin) following an Oct. 24 letter from the agency denying its citizen petition. Ivax claims exclusivity rights for Zocor 5 mg, 10 mg, 20 mg and 40 mg strengths and seeks to have two Merck patents re-listed in the "Orange Book." Ranbaxy filed suit against FDA Sept. 16 claiming exclusivity rights for the 80 mg dose of Zocor (1"The Pink Sheet" Oct. 31, 2005, p. 19). Both Ivax and Ranbaxy need a quick win to settle the matter; the compound patent for Zocor is set to expire June 23, 2006...

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